ClinicalTrials.gg
RecruitingNCT07703293Updated Jul 14, 2026

Nerve to Vastus Medialis Branches in Chronic Knee Pain

An observational study in Knee Osteoarthritis and Chronic Knee Pain, sponsored by Diskapi Teaching and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Diskapi Teaching and Research Hospital · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
45 Years to 80 Years
Sex
All
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Study summary

This observational cohort study aims to evaluate the clinical effect of adding ultrasound-guided pulsed radiofrequency treatment of the distal superficial and deep sensory branches of the nerve to vastus medialis to conventional genicular nerve radiofrequency treatment in patients with chronic knee pain due to knee osteoarthritis.

Adult patients aged 45-80 years with clinically and radiologically confirmed knee osteoarthritis and chronic knee pain lasting at least 3 months despite conservative treatment will be included. Patients will be followed according to routine clinical practice. Two cohorts will be evaluated: patients treated with conventional genicular nerve radiofrequency alone and patients treated with conventional genicular nerve radiofrequency plus pulsed radiofrequency of the distal sensory branches of the nerve to vastus medialis.

Pain intensity will be assessed using the Visual Analog Scale, and functional status will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index. Assessments will be performed before the procedure, at 1 month, and at 3 months after treatment. Adverse events recorded in patient files will also be evaluated.

Read the detailed description

Chronic knee pain related to knee osteoarthritis is mediated by a complex sensory innervation network. Although genicular nerves are commonly targeted in radiofrequency procedures for knee osteoarthritis pain, recent anatomical and ultrasound-based studies suggest that additional sensory branches may contribute to medial knee joint pain. The distal sensory branches of the nerve to vastus medialis have been described as contributors to the sensory innervation of the medial knee joint capsule.

In routine clinical practice, patients with chronic knee pain due to knee osteoarthritis may undergo ultrasound-guided conventional radiofrequency treatment of the genicular nerves. In some patients, pulsed radiofrequency treatment targeting the distal superficial and deep sensory branches of the nerve to vastus medialis may also be added. This study will compare clinical outcomes between these two routinely treated cohorts.

The study will include adult patients aged 45-80 years with knee osteoarthritis confirmed clinically and radiologically, Kellgren-Lawrence grade II-IV, chronic knee pain lasting at least 3 months, and insufficient response to conservative treatments. The primary outcome will be the change in pain intensity measured by the Visual Analog Scale from baseline to follow-up. Functional outcomes will be assessed using the WOMAC score. Evaluations will be performed at baseline, 1 month, and 3 months after the procedure. Safety outcomes will include procedure-related adverse events such as hematoma, infection, increased neuropathic pain, or transient motor impairment.

No additional intervention will be performed for research purposes, and treatment allocation will not be determined by the investigators.

02

Conditions studied

  • Knee Osteoarthritis
  • Chronic Knee Pain

Keywords

  • Genicular nerve
  • Nervus vastus medialis
  • Chronic knee pain
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 66 is below the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Diskapi Teaching and Research Hospital is the lead sponsor of 106 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will consist of adult patients aged 45 to 80 years with clinically and radiologically confirmed knee osteoarthritis and chronic knee pain lasting at least 3 months despite conservative treatment. Eligible patients will be those who are evaluated in the Algology Clinic and undergo ultrasound-guided genicular nerve radiofrequency treatment, with or without additional pulsed radiofrequency treatment targeting the distal sensory branches of the nerve to vastus medialis, as part of routine clinical practice. Patients will be included after providing written informed consent and will be followed for pain and functional outcomes at baseline, 1 month, and 3 months after the procedure.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age between 45 and 80 years Clinical and radiological diagnosis of knee osteoarthritis Kellgren-Lawrence grade II-IV knee osteoarthritis Chronic knee pain lasting at least 3 months Insufficient response to conservative treatments such as NSAIDs, physical therapy, or exercise programs Baseline Visual Analog Scale pain score ≥5 No coagulation disorder or active infection that would contraindicate the procedure Written provided by the participant

Exclusion criteria

Exclusion Criteria:

Knee pain primarily caused by conditions other than osteoarthritis, including inflammatory arthritis, septic arthritis, tumor-related causes, or infectious causes Previous total knee arthroplasty or knee prosthesis surgery in the affected knee Radiofrequency or neurolytic procedure around the affected knee within the last 6 months Severe knee instability, advanced deformity, or history of acute trauma Active infection, skin lesion, or ulceration at the procedure site Uncontrolled systemic disease such as advanced heart failure or uncontrolled diabetes Bleeding diathesis or inability to discontinue anticoagulant therapy for an appropriate duration Pregnancy or lactation Cognitive impairment, inability to cooperate, or inability to comply with follow-up visits

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (estimated)
Patient registry
No

Groups and cohorts

  • Conventional Genicular Nerve Radiofrequency

    Patients with chronic knee pain due to knee osteoarthritis who received ultrasound-guided conventional radiofrequency treatment targeting the genicular nerves as part of routine clinical practice.

    Procedure: Conventional Genicular Nerve Radiofrequency

  • Conventional Genicular Nerve Radiofrequency Plus Pulsed Radiofrequency Nerves Vastus Medialis

    Patients with chronic knee pain due to knee osteoarthritis who received ultrasound-guided conventional genicular nerve radiofrequency treatment plus pulsed radiofrequency treatment targeting the distal superficial and deep sensory branches of the nervus vastus medialis as part of routine clinical practice.

    Procedure: Conventional Genicular Nerve Radiofrequency · Procedure: Conventional Genicular Nerve Radiofrequency Plus Pulsed Radiofrequency of the Distal Sensory Branches of the Nerve to Vastus Medialis

Interventions

  • ProcedureConventional Genicular Nerve Radiofrequency

    Ultrasound-guided conventional radiofrequency treatment targeting the genicular nerves will be performed as part of routine clinical practice in patients with chronic knee pain due to knee osteoarthritis. Pain and functional outcomes will be evaluated using the Visual Analog Scale and WOMAC scores at baseline, 1 month, and 3 months after the procedure.

    Also known as: Genicular nerve radiofrequency ablation

  • ProcedureConventional Genicular Nerve Radiofrequency Plus Pulsed Radiofrequency of the Distal Sensory Branches of the Nerve to Vastus Medialis

    Ultrasound-guided conventional radiofrequency treatment targeting the genicular nerves will be combined with pulsed radiofrequency treatment of the distal superficial and deep sensory branches of the nerve to vastus medialis. This combined approach will be performed as part of routine clinical practice in patients with chronic knee pain due to knee osteoarthritis. Pain intensity and functional status will be assessed using the Visual Analog Scale and WOMAC scores at baseline, 1 month, and 3 months after the procedure.

    Also known as: Genicular nerve RF plus nerve to vastus medialis PRF

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What researchers measure

Primary outcomes

  1. Change in Visual Analog Scale Pain Score

    Change in knee pain intensity measured using the Visual Analog Scale. The score ranges from 0 to 10, with higher scores indicating more severe pain.

    Time frame: Baseline, 1 month, and 3 months after the procedure

Secondary outcomes

  1. Change in WOMAC Score

    Change in knee osteoarthritis-related pain, stiffness, and physical function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores indicate worse symptoms and functional impairment.

    Time frame: Baseline, 1 month, and 3 months after the procedure

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Saena S, Sukhonthamarn K, Kosuwon W, Apinyankul R, Witayakom W. Anatomical presentation of the nerve to vastus medialis within the adductor canal and femoral nerve branch insertions into thigh muscles: a cadaveric study. Surg Radiol Anat. 2025 Oct 31;47(1):250. doi: 10.1007/s00276-025-03763-0. PubMed 41174247 ↗
  • Orduna-Valls J, Ferreira-Silva N, Acevedo C, Cunat T, Araujo-Cernuda R, Vallejo R, Ribeiro-da-Silva T, Pena I, Ferreira-Dos-Santos G. The nerve to vastus medialis as a target for treating chronic medial knee joint pain: an ultrasound-based anatomical localization study in healthy subjects. Pain Med. 2026 Feb 1;27(2):170-176. doi: 10.1093/pm/pnaf111. PubMed 40828883 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07703293
Responsible party
Damla Yürük (Supervisor Investigator, Diskapi Teaching and Research Hospital) — Principal investigator
First posted
Jul 14, 2026
Start date
May 20, 2026
Primary completion
Aug 20, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Jul 14, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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